Drug establishmentActive, Registered FY2026FDA warning letter on file

Acme United Corporation

Acme United Corporation is an FDA-registered drug establishment (FEI 1030186) located in , North Carolina. The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Oct 10, 2025

CGMP/Finished Pharmaceuticals/Adulterated

Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number

1030186

Address

2280 Tanner Rd, , North Carolina

Establishment type

Drug establishment

Products / operations

LABEL; PACK; RELABEL; REPACK

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

None on file

Form 483 observations

None on file

FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.

Questions

Is Acme United Corporation registered with the FDA?

Yes. Acme United Corporation is an FDA-registered drug establishment (FEI 1030186) in , North Carolina. Its current registration status is Active, Registered FY2026.

Has Acme United Corporation received an FDA warning letter?

Yes. FDA issued a warning letter to Acme United Corporation; the most recent is dated Oct 10, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Acme United Corporation do?

Acme United Corporation's FDA-registered operations are: LABEL; PACK; RELABEL; REPACK.

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Source: FDA public data · status as of 2026-06-01